The following data is part of a premarket notification filed by Trek Diagnostic Systems with the FDA for Autoreader 2.
| Device ID | K103532 |
| 510k Number | K103532 |
| Device Name: | AUTOREADER 2 |
| Classification | Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems |
| Applicant | TREK DIAGNOSTIC SYSTEMS 982 KEYNOTE CIRCLE Cleveland, OH 44131 |
| Contact | Cynthia Knapp |
| Correspondent | Cynthia Knapp TREK DIAGNOSTIC SYSTEMS 982 KEYNOTE CIRCLE Cleveland, OH 44131 |
| Product Code | LRG |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-01 |
| Decision Date | 2011-08-26 |